Treating Depressed Mood With a Smartphone-delivered Positive Word Stimulation for Subthreshold Depression

Not Applicable

Completed

• Conditions: Subthreshold Depression

• Registration Number: NCT04707495
• Lead Sponsor: Gunma University

Brief Summary

Major depressive disorder (MDD) is an important public health problem. Thus, preventive interventions against subthreshold depression (StD), which is one of the key risk factors for the development of MDD, are important. The study developed a smartphone application (SPSRS) that improves depressive symptoms in people with StD by automatically presenting positive word stimuli during videos. The SPSRS application has the potential to improve depressive symptoms in people with StDs. However, whether it can immediately improve depressed moods in people with StD is unclear. The study aims to investigate the immediate effects of SPSRS applications on depressed mood in people with StD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-11
• Study First Posted: 2021-01-13
• Study Start: 2021-03-04
• Primary Completion: 2021-06-14
• Study Completion: 2021-06-14
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-30
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Male and female
2. 20 to 39 years old
3. Beck Depression Inventory-II (BDI-II) score of 10 points or more
4. Persons with written informed consent prior to participation

Exclusion Criteria

1. History of mental illness
2. Currently receiving treatment from a professional for mental health issues
3. Vision or hearing problems that interfere with daily life.
4. With a major depressive episode in the last two weeks according to the Mini-International Neuropsychiatric Interview

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Profile of Mood States 2nd Edition-Adult Short (POMS 2-A Short)	Change of POMS 2-A Short from baseline at the end of 10 minutes of intervention.	The POMS 2-A Short is a 35-item self-administered questionnaire used to measure mood states. Items are rated using a 5-point Likert-type scale (0 = not at all, 1 = a little, 2 = moderately, 3 = quite a lot, and 4 = extremely). The POMS 2-A Short assesses seven domains, namely, anger-hostility, confusion-bewilderment, depression-dejection, fatigue-inertia, tension-anxiety, vigor-activity, and friendliness. High scores indicate better vigor-activity and friendliness are better but more severe symptoms of the five other domains. In addition, the Total Mood Disturbance (TMD) score is calculated from anger-hostility, confusion-bewilderment, depression-dejection, fatigue-inertia, tension-anxiety, and vigor-activity. TDM is calculated based on a standard value (mean of 50 and standard deviation of 10).

Secondary Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory State (STAI-S)	Change of STAI-S from baseline at the end of 10 minutes of intervention.	The STAI is a self-administered questionnaire consisting of two scales that each assesses state anxiety and trait anxiety. Each scale consists of 20 items. Items for STAI-S are scored using a 4-point Likert-type scale (1 = not at all, 2 = somewhat, 3 = moderately so, and 4 = very much so) with the total score ranging from 20 to 80 points. The higher the score, the greater the state anxiety.

Trial Locations

Locations (1)

Gunma University; 🇯🇵 Maebashi, Gunma, Japan